FDA UDI
In Commercial Distribution
🇺🇸 United States
PROFILE EMS
DI: 05060079210347
·
Model: EM-PROFILE_EMS
·
BODY CLOCK HEALTH CARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PROFILE EMS
- Primary DI
- 05060079210347
- Version / Model
- EM-PROFILE_EMS
- Company Name
- BODY CLOCK HEALTH CARE LIMITED
- Labeler DUNS
- 504712829
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-02-12
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- eb2ba8e6-657d-449e-9eec-2e04fd559b7f
Device Description
The PROFILE EMS is a symmetrical biphasic neuromuscular electronic stimulator intended for medical purposes, which repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. It is indicated for the following: - Prevention or retardation of muscle disuse atrophy; - Relaxation of muscle spasm; - Muscle reeducation; - Maintaining and increasing the range of motion; - Increasing local blood circulation; - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | Physical Medicine | 890.5850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17908 | Physical therapy ultrasound/neuromuscular stimulation system | An assembly of devices that includes a neuromuscular electrical stimulator as an integral part of a therapeutic ultrasound system intended for the simultaneous delivery of ultrasound and electrical energies for physical therapy, typically to help prevent scar tissue formation in healing tissues and to help reduce muscle spasms and pain; it may in addition be capable of delivering either energy alone. The system is designed to produce a rhythmic contraction/release of injured muscles to promote the removal of metabolic by-products while applying ultrasound treatments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060079210347 | GS1 |